Clinical Studies Made on Generic Norvasc Amlodipine Besylate
Generic Norvasc Amlodipine Besylate belongs to a family of medications called calcium channel blockers. These medications block the transport of calcium into the smooth muscle cells lining the coronary arteries and other arteries of the body.
Clinical Studies
Adult Patients
Several studies have been made to test the antihypertensive efficiency of Generic Norvasc Amlodipine Besylate. It was revealed in a total of 15 double-blind, placebo-controlled, randomized studies. As many as 800 patients on this drug and 538 on placebo were included in these studies.
Once daily administration resulted in statistically noteworthy placebo-corrected decrease in supine and standing blood pressures at 24 hours postdose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension. It exhibited maintenance of the blood pressure effect. The 3 parallel, fixed dose, dose response studies showed that the decrease in supine and standing blood pressures varied based on amount of dose within the recommended dosing range. Both young and older patients showed similar effects on diastolic pressure.
Pediatric Patients
In a randomized study made on 268 hypertensive patients aged 6 to 17 years first to Norvasc 2.5 or 5 mg once daily for 4 weeks, lower blood pressure was observed than those secondarily randomized to placebo.
Effects in Chronic Stable Angina
In 8 placebo-controlled, double-blind clinical trials which included 1038 patients (684 Norvasc, 354 placebo) with chronic stable angina, the effectiveness of 5–10 mg/day in exercise-induced angina has been studied up to 6 weeks duration. A 10 mg dose enhanced exercise time (bicycle or treadmill) in 5 of the 8 studies.
A 10 mg of this drug also increased time to 1 mm ST segment deviation in several studies and decreased angina attack rate. The same dose showed increase in symptom-limited exercise time averaging 12.8% (63 sec) and averaging 7.9% (38 sec) for NorvascAmlodipine 5 mg.
Effects in Vasospastic Angina
Therapy with this drug decreased attacks by around 4/week compared with a placebo decrease of approximately 1/week (p<0.01) in a double-blind, placebo-controlled clinical trial of 4 weeks duration in 50 patients. Two of 23 Norvasc Amlodipine and 7 of 27 placebo patients stopped from the study because of deficiency of clinical improvement.
Effects in Documented Coronary Artery Disease
In a randomized study of Norvasc (5–10 mg once daily) or placebo followed for 3 years, 825 patients with angiographically reported coronary artery disease. Although the study did not show significance on the primary objective of change in coronary luminal diameter as evaluated by quantitative coronary angiography, the data suggested a favorable outcome regarding fewer hospitalizations for angina and revascularization procedures in patients with CAD.
Studies in Patients with Congestive Heart Failure
A comparison was made between Norvasc and placebo in four 8–12 week studies of patients with NYHA class II/III heart failure which showed no evidence of worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms, or left ventricular ejection fraction. A total of 697 patients took part in these studies.